Theory exam will be made at the end of the teaching period. There will not be a second-chance examination on June. The theory exam will have the format of multiple-choice questions (5 answers of which only one will be valid). In the rest of exams and practices the format will be short-answers questions. The theoretical exam will evaluate the content of (see Program of the subject):  Capítulo 5 Harrison, “Principios de Medicina Interna”, 18ª ed., McGrawHill, 2012 (español).  Capítulos 61, 64, 65, 66, 67, 72, 73, 74 y 76 de Velázquez, “Farmacología Básica y Clínica”, 19ª edición, Panamericana, 2018.  Orden SAS 3470/2009: artículos 3, 4, 5, aptdo 2 del Art 6 y Art 7; Definición de: Estudios EPA-LA, EPA-AS, EPA-SP, EPA-OD, NO-EPA; Cuadro 1.  Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios, en su texto consolidado de 2015, en los siguientes artículos: Art 3, apartado 6; Art 7, Aptdos 1, 2 y 4; Art 8; Art 12; Art 13; Art 14, Aptdos 1 y 2; Art 15, Aptdos 2, 3 y 4; Art 19, Aptdos 1, 2, 3 y 4; Art 24, Aptdo 3; Art 46, Aptdo 1; Art 47, Aptdos 1 y 2; Art 50; Art 51; Art 53, Aptdos 1 y 2; Art 54, Aptdo 3; Art 58, Aptdos 1 y 3; Art 60; Art 62; Art 77, Aptdos 1, 3, 4 y 5; Art 82, Aptdo 1; Art 85; Art 86; Art 101. The theoretical mark will be the one reached in the theoretical exam. The mark of public expositions will be: written report mark x 0.6 + public exposition mark x 0.4 2.6. The practical mark will be obtained by adding up the qualifications of the 3 practices. Each mark will have a maximum value of 2.5 out of 10, except the clinical trials practice (practice 1), whose value is 5 out of 10. The qualifications of the practices will be done as follows: Practice 1 (clinical trials) and Practice 3 (pharmacokinetics): a) Continuous evaluation by the teacher of the student's activity (attitude, training and acquisition of skills) during the 5 days of practice b) Test performed on day 4 of practices. Practice 2 (pharmacovogilance): a) Yellow card: 30% of the qualification b) Causality algorithm: 40% of the qualification c) Evaluation of the risk/benefit ratio of the drug suspected of causing ADR including the severity of ADR: 30% of the practice score. The student who has not completed all the practices, including assistance and evaluation, will not pass the subject. The final mark of the subject will be calculated as follows: Final theoretical grade: theoretical mark x 0.3. Final practice grade: practice mark x 0.4. Exposition grade x 0.3. Grade of the subject: sum of the previous three grades. The overall grade will be established in a meeting of the teachers of the subject. The student who does not pass the subject in a first call could applies on subsequent calls only making subject parts that they have not passed (practices, exposition, theoretical examination), until the overall grade will be 5. Claims of the qualifications of the exams will be done according to the exam regulation of University Miguel Hernandez. To arrange a personal tutorial contact with the secretary of the Department of Pharmacology and Pediatrics (965919488), or with the secretary of the Clinical Pharmacology Unit of the General University Hospital of Alicante (965913868). The tutoring schedule will be from Monday to Friday from 9 to 13 AM.